A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-07-02. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placeborandomizationthe opinionopinion ofthe investigator
  Phrases that lowered it: participantsparticipantthe effectevaluateeffect of
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Sponsor's past trials: 690 (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 55 (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Blinding: double (raises risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Collaborators: 0 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Study of M5049 in DM and PM Participants (NEPTUNIA) NCT05650567 · started 2023 · scored riskier than 93% of active trials terminated
• Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis NCT03686969 · started 2018 · scored riskier than 71% of active trials terminated
• Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy NCT02971683 · started 2017 · scored riskier than 54% of active trials completed
• A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments NCT03981744 · started 2019 · scored riskier than 52% of active trials terminated
• Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis NCT04976140 · started 2021 · scored riskier than 38% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.